Sofosbuvir/velpatasvir combo to treat HCV in children

April 4, 2020 0 By FM

The US FDA has approved a supplemental New Drug Application (sNDA) for sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg (Epclusa) for the treatment of people with chronic hepatitis C infection (HCV) as young as 6 years of age or weighing at least 17 kg, regardless of HCV genotype or liver disease severity.

The sofosbuvir/velpatasvir combo is the first pan-genotypic, protease inhibitor-free regimen approved in the United States for adults and children, Gilead Sciences Inc said.

The approval of sofosbuvir/velpatasvir is based on data from a phase 2, open-label clinical trial (Study 1143) that enrolled 175 children who were treated with Epclusa for 12 weeks, of which 173 were included in the efficacy analysis. In children 12 to <18 years old, treatment with the combination therapy resulted in a cure rate (SVR12) of 93 percent (71/76) in those with genotype 1 HCV infection and 100 percent in those with genotype 2 (6/6), genotype 3 (12/12), genotype 4 (2/2) and genotype 6 (6/6) HCV infection. 

In children 6 to <12 years old, the SVR rate was 93 per cent (50/54) in those with genotype 1 HCV infection, 91 percent (10/11) in those with genotype 3 HCV infection, and 100 percent in those with genotype 2 (2/2) and genotype 4 (4/4) HCV infection.